# K212308: SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Srirungruang Global Co., Ltd.
- Decided: Oct 29, 2021 after 98 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022548 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192333: Blue Nitrile Examination Gloves Powder Free, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2020) Summary page 5.

## Indications for use
SHARK GLOVES and ICONGLOVE Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K212308
Methodology: https://510kreport.com/methodology